SOP for Product Recall

PURPOSE

To establish the procedure to discontinue the distribution and sale of a batch of a product and retrieve (Recalled) unsold stock of the batch under question from the market promptly and effectively.

SCOPE

This procedure is applicable for drug products manufactured by Company Name for domestic as well as Export markets.

RESPONSIBILITY

Head- Quality Assurance

To investigate defective drug products and implement corrective action and preventive action.

To co-ordinate the recall by providing the required Details.

Disposition of the recalled Product.

ACCOUNTABILITY

Tech Director

• To receive and assess reports of suspected defective drug products.
• To advise and monitor necessary actions and recall and reconciliation.
• To communicate with relevant agencies

PROCEDURE

Definition:

Defective drug product

During the manufacturing or distribution of a drug product, an error or incident may occur whereby the drug product does not conform to its specification or is for some other reason defective (e.g. presence of a contaminant that may not be detected during routine analysis). Such a defect may impair the therapeutic effect of the product and could adversely affect the health of the patient.

Withdrawal:

The drug products are taken back from the market.

Recall:

Removal of a specific batch (es) of the drug product.

Recall decision:

Drug products shall be recalled in case of forced recall (can be due to Instruction from Regulatory or health authorities).

Voluntary recall:

Voluntary recall may be due to the following reason(s)

1. Product Mix-ups
2. Non-conforming results of ongoing stability study
3. Labeling errors
4. Damage of containers/closures holding the products during storage/transit
5. Excess supply to the customers
6. Market complaint
7. Expired Product
8. Minimizing the regulatory involvement
9. Any other reasons

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The Tech Director shall nominate the person for initiating an investigation, coordination, and product recall.

• An investigation for the correctness of reported defects shall be carried out independently by the Head-QA, Head-Production supported by Head-Marketing and Distribution.
• The investigation shall cover but not limited to:

1. The control sample (Inspection and if required analysis)
2. Stability study data
3. Transpiration, Distribution & Storage
4. Consumption & usage by user
5. Pre and Post batches manufactured
6. Product with the same formulation type
7. Same product with different strengths

• In case of either of recall (forced or Voluntary) Tech director shall assess the situation/complaint / Instruction.

Classification of Recall

Based on the investigation data, the Head QA shall categorize the recall:

Class-I

The defect presents a life-threatening or serious risk to health.

Class –II

The defect may cause mistreatment or harm to the patient, but it is not life-threatening.

Class-III

The defect is unlikely to cause harm to the patient, and the recall is carried out for other reasons, such as non-compliance with the marketing authorization or specification.

Class IV

Where there is no threat to the patient or no serious defect likely to impair product use or efficacy. They are generally used for minor defects in packaging or other printed materials.

They can be called “Caution in use” defects.

For investigation and further action following details shall be made available by the concerned department head, agency, and personnel authorities.

1. Product details
2. Brand name
3. Strength
4. Pack size
5. Batch No. / Lot No.
6. Manufacturing date / Expiry date
7. Any other details identifying the product/batch
8. Mfg license No.
9. Actual sample pack or photocopy
10. Nature of defect

• The Tech Director and Head – QA shall jointly investigate the defect concerning:

1. Nature and genuineness of defect.
2. Causes of the defect (if not clearly identified probable cause).

• As and when required head QA shall seek the details, data, and documents from Location, Regulatory, Marketing and Distribution and other concerned departments.
• Based on the investigation, Head-QA shall suggest for classification of product recall.
• Product recall shall be initiated in case of justified reasons like:

1. The drug product proves to be harmful under normal conditions of use.
2. The drug product is lacking in therapeutic efficacy.
3. The qualitative and quantitative composition of the product is not as declared.
4. The control on the drug product and/or on the ingredients and the controls at an intermediate stage of the manufacturing process has not been carried out or if some other requirement or obligation relating to the grant of the manufacturing authorization has not been fulfilled.

• Head- QA shall forward the observations and suggestions for a product recall to the Director/Tech. Director.
• Once the product recall is authorized by the director/Tech. The director and head–QA nominated for the product recall shall inform head- of marketing and distribution to:

1. Discontinue distribution/sale of products. Retrieve unsold stock from the market and under transit.
2. Action to be taken (within the time frame/ immediately) to quarantine stock/ return stock.

• Both objectives shall be served by sending suitable communication to company distributors, wholesalers, field staff, and agents through by Head- of marketing and distribution.
• Records of distribution shall be used for sending recall notifications as per Annexure-II.
• For Domestic Recall- The distribution details of the batch shall be available from the distribution record(hardcopy/software as applicable). For a reconciliation of other batches, data can be available from the record of distribution depot stock, plant warehouse stock from electronic software, and WIP stock from BPR.
• For recall by contract Givers- Distribution details of the batch will be available to Contract givers through their own system. If information is received from the Contract giver for reconciliation of other batches, data can be available from the record of depot stock, plant warehouse stock from electronic software, WIP stock, from bath manufacturing record.

Recall notification shall include:

Recall details

1. Nature of recall
2. Recall class-I/II/III/IV
3. Level of recall (distributor level, retail level, pharmacy, user level)
4. Reason for recall
5. Date of recall or withdrawal

Volume of recall

1. Quantity manufactured
2. The quantity consumed/ retained / underhold
3. Quantity Distributed
4. Estimated quantity in the market (distributor level, retail level, pharmacy, user level)

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Product Details

1. Brand name
2. Strength
3. Pack size
4. Batch No. / Lot No.
5. Manufacturing date
6. Expiry date
7. Any other details identifying the product/ batch
8. Product license (PL Number), if applicable
9. Packing details (Product labeling)
10. Actual sample pack or photocopy
11. Promotional material(if applicable)
12. Nature of defect.
13. Details of defects
14. Direction of use/ Route of administration
15. The account of any action taken in consequence

Recalling firm details

1. Name(s) of firm
2. Contact person along with contact number (office hours and off hours)
3. Firm address, city, state, country, zip code

Distribution details (names/address/city/state/contact name/phone number)

1. Wholesalers
2. Distributors
3. Re-packers
4. Retail/pharmacy/veterinarian,
5. Users/customers, (medical, hospitals, clinics, laboratories)
6. Government Consignee
7. Foreign consignees (specify whether they are wholesale distributors, retailers or users)
8. Geographic areas of distribution, including foreign countries.

• Head- QA shall be forward all the above details to all concerned personnel, authorities, agencies, and departments through mail, fax, telephone or by any other means

Recall Strategy:

Based on observation, investigation and above information Head-QA shall decide the recall Strategy.

The strategy shall include

1. Method of notification
2. Notification to Regulatory Agency/ Authority(Local/ Export Country)
3. Notification to contract giver
4. Mechanism of recall
5. Impact on the consumer(if this recall will create a market shortage that will)
6. Recall effectiveness check
7. The course of action for out-of-business distributors
8. Possible ways of addressing the defect
9. Disposition of Recalled Product

• Head Marketing and distribution (Local/Export) shall immediately arrange to freeze All stocks of the Specified Product/ Batch lying with distributors, agents, and Customers.
• Head Market shall also instruct the entire sales force to freeze the further sale of product/batch at every distribution, sales point (stockiest, chemist, doctors, Hospitals etc.) This also shall include goods under transit.
• Head Marketing and distribution shall send a product recall circular immediately upon receiving the product recall notification to all concerned persons requesting them to all stock of the product / Batch under question to the depots and informing them that a credit note for the stocks returned shall be issued to them at the earliest.

Notification:

• Based on recall details and recall strategy head-QA shall decide the method of notification.
• This is to get the message accrues to the relevant consumers quickly enough to minimize the risk of injury.
• The notification shall include the Details as stated above.
• For notification one or more of (or any combination thereof) the following shall be considered.

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Publicizing recalls in newspaper & printed media

1. Advertise in daily or community newspaper
2. Display signs in retail outlets for the product.
3. Issue a media release to newspapers.
4. Ask relevant industry and community organizations to publicize the recall in their newsletters.
5. Advertise in special interest publication if appropriate Recall notification shall be Clear and bold

Electronic communication Media:

1. Advertise on radio and television.
2. To ensure the broadest coverage, press releases should be issued through the associated press.
3. Posting the recall notification on the website.

• Notification is by phone.
• In case of recall as per directives of competent or Regulatory Authorities, the information shall be forwarded to them.
• Complete Reconciliation of stock of the batch manufactured/distributed and subsequently quantity of stock received back shall be intimated to Competent / Regulatory Authorities.
• In case of recall initiated by our company (voluntarily), this shall be informed to the Regulatory Authority.
• In the event of recall is initiated by the Contract Adopter, the initiation of the same shall be forwarded to the authorized person of Contract Given by the Technical Director.
• In the event of recall being initiated by the Contract Giver, the intimation has to be given to the Contract Acceptor by the authorized signatory of the Contract Giver.
• The Contract Giver shall take the required action for the recall and intimate the quantity of goods received from the market.
• In case of a Contract Giver product recall, the report of the Contract giver and contract adopter will be co-related and a compiled report of reconciliation shall be made. This report shall be kept by both the contract giver and the contract adopter.
• The record of the disposal of recalled goods shall be taken mutually by the Contract Giver and Contract Adopter.
• The records of the disposal of recalled goods shall be retained at both ends.

• The decisions, activities, and actions including the progress of recall shall be documented and duly authorized.
• On completion of the recall procedure, the summary report shall be prepared which shall include the following reference

1. Reason for recall of a product (with batch no. and other details about the product).
2. Effectiveness of recall.
3. Corrective action to prevent recalls.

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• The total cost incurred due to recall.
• This summary report shall be prepared by the Quality Assurance Head as per Annexure III and be circulated to all concerned departments (Production, Finance, Sales) and the Managing Director, Tech. Director.
• In case of regulatory-originated recalls the former closer shall be done only after receipt of the final report from the regulatory authority.
• Refer to Annexure-I closure of product recall.
• The effectiveness of the system of recall shall be evaluated at least once in every four years or whenever the distribution chain is changed by MOC Exercise.
• The MOC Exercise shall be done in coordination with the Head of Marketing.

REFERENCES

cGMP Guideline

ANNEXURES

Annexure I - PRODUCT RECALL / WITHDRAWAL

Annexure II - RECALL NOTIFICATION (SPECIMEN)

Annexure II - SUMMARY REPORT OF RECALL / WITHDRAWAL

ABBREVIATIONS

SOP: Standard Operating Procedure

QA: Quality Assurance

MOC: Maintenance operational check

BPR: Batch Processing Record

CQA: Corporate Quality Assurance

REVISION HISTORY

Nil

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